April data and first quarter earnings reports show remarkable resilience in med tech, even as other sectors continue to suffer in response to tariffs and changing regulations. Not that tariffs proved insignificant: several companies reported annualized impacts north of half a billion dollars, but fundamentals and increased interest in med tech as a haven gave most players sufficient breathing room to absorb the impact with minimal adjustments.

Echoing President Donald Trump’s justification for reciprocal tariffs, the U.S. Trade Representative’s annual Special 301 Report is a bit more aggressive in tone this year as it calls out trading partners that don't adequately enforce intellectual property rights or that otherwise discriminate against products from foreign companies.

The U.S. Department of Justice may have dismantled its civil division, but that doesn’t mean companies in the life sciences can let their guard down.

Physicians aren’t the only ones who see prior authorization (PA) practices as a significant problem, but John Brooks, deputy administrator at CMS, told a med tech audience that a renewed focus on Medicare Advantage plans’ use of PA will not yield tangible results overnight.

Following a complete response letter last year, Satsuma Pharmaceuticals Inc. received U.S. FDA approval of dihydroergotamine nasal powder to treat acute migraine with or without aura. Branded Atzumi, it is the first product that uses Satsuma’s SMART (Simple MucoAdhesive Release Technology) platform that combines an advanced powder and device technology aimed at making delivery more simple.

First quarter 2025 results presentations were the first chance analysts have had to quiz pharma companies in public about their exposure to the threat of U.S. import tariffs and what action they are taking to mitigate the risks. BioWorld reporters have listened in to the analyst meetings and filleted out responses to the tariff question by CEOs and senior executives, to get an overview of how the sector as a whole is responding. One thing is very clear: While pharmaceuticals are for now exempt from tariffs, the industry has been bracing for their imposition whilst at the same time lobbying strongly against them, on the grounds that drug shortages could result.

Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health (CDRH), covered several programmatic areas in a May 1 trade association meeting, such as the CDRH early alert program.

Sen. Amy Klobuchar (D-Minn.) spoke to an industry meeting in Washington and expressed concerns about the situation at the U.S. FDA, but she also blasted the tariffs put in place by the Trump administration as lacking the proper statutory authority.